ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer

NCT03294889 | Recruiting Phase 1 DMC

• 1 other identifier: 2017-01236
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the phase I/II trial is to determine the safety and efficacy of a single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Stereotactic body radiation therapy; Calypso® beacon system

Outcome Measures

Primary Outcomes (2)

• Clinical performance

  Toxicity will be evaluated using Grade ≥ 3 genitourinary and/or gastrointestinal acute adverse event (AE) during the first 3 month according to CTCAE classification v.4.03 (Phase I).

  3 months

• Progression free survival (PFS)

  The primary endpoint is 3-years biochemical relapse free survival (bRFS). bRFS and its 97.5% one-sided confidence interval (CI) will be determined using the Kaplan Meier method. If the expected value of 96% isn't included in this interval, the efficacy of the experimental treatment will be questioned. (Phase II).

  3 years

Interventions

Stereotactic body radition (SBRT) RADIATION

Ultra-hypofractionated single-fraction SBRT with urethra-sparing with image-guidance and intra-fractional control motion with the Calypso® system. * 19 Gy in a single fraction to the whole prostate gland ± proximal seminal vesicles * 17 Gy in a single fraction to the urethra planning-risk volume (PRV)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Histologically confirmed adenocarcinoma of the prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
• Histologically confirmed adenocarcinoma of the prostate without small cell features
• Tumor clinical stage cT1c-2c, pN0 or cN0, M0, according to UICC TNM 2009
• MRI staging must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c
• Gleason score at biopsy 3+3 or 3+4 (WHO 2016 Grade Groups 1, 2)
• PSA ≤15 ng/ml
• WHO performance status 0-1
• International Prostate Symptom Score ≤ 10 (alpha blockers allowed)
• MRI-based volume estimation of prostate gland ≤ 70 cc
• Patient agrees not to father a child during trial treatment and during 6 months thereafter

You may not qualify if:

• Tumor clinical stage cT3a-3b or T4
• Evidence of T3a, T3b or T4 disease as assessed by MRI
• Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies.
• Significant tumor on the transitional zone as assessed by MRI
• Gleason at biopsy ≥ 4+3
• Androgen deprivation therapy or products known to affect PSA levels
• Impossibility to implant Calypso beacons
• History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of curatively treated localized non-melanoma skin cancer
• Prior pelvic radiotherapy
• Previous surgery for prostate cancer
• Previous transurethral resection of the prostate (TURP) (\< 12 weeks before registration)
• Hip prosthesis
• Severe or active co-morbidity likely to impact on the advisability of SBRT
• Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Humanitas Hospital, Italy: collaborator
• University of Zurich: collaborator
• Kantonsspital Graubünden: collaborator

Study Sites (1)

University Hospital of Geneva

Geneva, 1205, Switzerland

RECRUITING

Related Publications (1)

• Zilli T, Scorsetti M, Zwahlen D, Franzese C, Forster R, Giaj-Levra N, Koutsouvelis N, Bertaut A, Zimmermann M, D'Agostino GR, Alongi F, Guckenberger M, Miralbell R. ONE SHOT - single shot radiotherapy for localized prostate cancer: study protocol of a single arm, multicenter phase I/II trial. Radiat Oncol. 2018 Sep 4;13(1):166. doi: 10.1186/s13014-018-1112-0.

  PMID: 30180867 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Thomas Zilli, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Zilli, MD

CONTACT

+41 79 55 32 563; Thomas.Zilli@hcuge.ch

Laurence Zulianello, PhD

CONTACT

+ 22 372 72 05; laurence.zulianello@hcuge.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Médecin Adjoint Agrégé

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: September 1, 2017
• Primary Completion: October 1, 2022
• Study Completion (Estimated): October 1, 2030
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)